Recall Z-2499-2020— Smiths Medical ASD Inc.

Name: FDA recall Z-2499-2020
Creator: U.S. Food and Drug Administration
Published: 2020-06-11

Class II · Terminated

Class II FDA medical device recall by Smiths Medical ASD Inc., initiated 2020-06-11, terminated 2021-01-25. It names one FDA 510(k) clearance: K072657. Product: PORT-A-CATH¿ II POWER P.A.C. Low Profile" system.. Reason: Smiths Medical became aware that one (1) lot of PORT-A-CATH¿ II POWER P.A.C. Low Profile" System (SKU 21-4477-24) was packaged with an 8Fr catheter instead of a 6Fr catheter..

Recalling firm: Smiths Medical ASD Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-06-11
Terminated: 2021-01-25
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K072657 — POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUSSmiths Medical MD, Inc.·cleared 2007-12-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

PORT-A-CATH¿ II POWER P.A.C. Low Profile" system.

Reason for recall

Smiths Medical became aware that one (1) lot of PORT-A-CATH¿ II POWER P.A.C. Low Profile" System (SKU 21-4477-24) was packaged with an 8Fr catheter instead of a 6Fr catheter.

Data sourced from openFDA. This site is unofficial and independent of the FDA.